Efficacy and Safety Study of ME1111 in Patients With Onychomycosis

Onychomycosis Clinical Trial

Official title:

A Phase 2 Randomized, Double-Blind, Vehicle-Controlled, Dose-Ranging Study to Investigate the Efficacy and Safety of ME1111 in Patients With Mild to Moderate Onychomycosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02022215
• Other study ID #: ME1111-2
• Status: Completed
• Phase: Phase 2
• Start date: December 19, 2013
• Est. completion date: March 1, 2016

Study information

• Verified date: March 2024
• Source: Meiji Seika Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the safety and efficacy of high and low strength of ME1111 solutions compared to the vehicle in the treatment of onychomycosis of the toenail.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: March 1, 2016
• Est. primary completion date: October 28, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Mild to moderate distal lateral subungual onychomycosis

• A positive potassium hydroxide (KOH) microscopy

• A positive fungal culture for a dermatophyte

• Good general health

Exclusion Criteria:

• Uncontrolled diabetes

• Onychomycosis of the fingernails

• Prior use of antifungal drugs (Failure to complete the specified washout period)

• History of HIV, Hepatitis B or Hepatitis C

• Diagnosis of psoriasis or history of psoriasis

• Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study

• Pregnancy/lactation

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• ME1111 Solution, Low strength
ME1111 Solution, Low strength, applied once daily for 48 weeks
• ME1111 Solution, High strength
ME1111 Solution, High strength, applied once daily for 48 weeks
• Matching Vehicle Solution
Matching Vehicle Solution, applied once daily for 48 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meiji Seika Pharma Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete cure rate at Week 52	complete cure :clear (zero %) clinical involvement of the target great toenail and mycologic cure.	Week 52
Secondary	Complete or almost complete cure rate at Week 52	complete or almost complete cure:5 % or less clinical involvement of the target great toenail and mycologic cure.	Week 52
Secondary	Number of Adverse events		Up to Week 48, Week 52, EOS
Secondary	Local Tolerability Assessments	Local Tolerability Assessments:Burning/Stinging, Pruritus, Dryness, Scaling, Erythema, General Irritation, Induration/Edema, Oozing/crusting.	Up to Week 48, Week 52, EOS